Approximately 70% of newly-diagnosed NSCLC cases occur in the elderly, and more than half are locally advanced/metastatic. We present a pooled analysis of efficacy and safety in elderly pts (aged ≥75 y) enrolled in 3 randomized controlled trials of pembro monotherapy vs standard chemotherapy (chemo) for PD-L1–positive advanced NSCLC.

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Methods

Pts were aged ≥18 y with advanced NSCLC with PD-L1 tumor proportion score (TPS) ≥1% (KEYNOTE-010, -042) or TPS ≥50% (KEYNOTE-024). In KEYNOTE-010, pts were randomized to pembro 2 or 10 mg/kg Q3W or docetaxel, as second- or later-line therapy. In KEYNOTE-024 and -042, pts were randomized to first-line pembro 200 mg Q3W or platinum-based chemo. OS was estimated by the Kaplan-Meier method.

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Eligible pts enrolled in Japan during the global or extension study of KEYNOTE-189 were randomized 2:1 to pembro 200 mg Q3W or placebo for up to 35 cycles (∼2 y); all pts received pem 500 mg/m2 (until progressive disease or intolerable toxicity) and 4 cycles of carboplatin AUC 5 or cisplatin AUC 75 mg/m2. Safety and tolerability were assessed by clinical review of all relevant parameters; adverse events (AEs) and laboratory abnormalities were graded per NCI CTCAE v4.0.

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Results

Of 40 pts enrolled in Japan (global study, n = 10; extension study, n = 30), 25 were randomized to the pembro arm, and 15 to the placebo arm. There were no meaningful differences in baseline characteristics, apart from a smaller proportion of pts with brain metastases (16% vs 33%), and larger proportion with PD-L1 TPS <1% (56% vs 40%) and cisplatin recipients (72% vs 53%) in the pembro vs placebo arm, respectively. The median (range) follow-up was 5.6 (2.4–12.9) mo and 7.0 (2.4–19.8) mo in the pembro and placebo arms, respectively. There were no deaths due to AEs. Grade 3/4 AEs occurred in 13 pts (52%) in the pembro arm and 8 (53%) in the placebo arm. 6 (24%) vs 3 pts (20%) had immune-mediated AEs and infusion reactions, with no events of pneumonitis reported in the pembro arm vs 2 (13.3%) in the placebo arm. Overall, AEs led to treatment discontinuation in 4 (16%) pts in the pembro vs 3 (20%) pts in the placebo arm.

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Conclusions

Pembro + pem + platinum demonstrated a tolerable and manageable safety profile in Japanese pts, generally consistent with the overall pt population in the global KEYNOTE-189 study. No new safety concerns were identified in Japanese pts.

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